Apparatus for delivering high intensity focused ultrasound energy to a treatment site internal to a patient&#39;s body

ABSTRACT

An apparatus for delivering HIFU energy may include a probe with a plurality of leaves that provide a bowl-shaped HIFU therapy transducer. In once case, pins may slide within grooves in the leaves to deploy the leaves. In another case, spines may be configured to slide in a channel defined in each leaf. In other cases, a spring or a shape memory alloy may be used to deploy the leaves. In another implementation, a probe may be fitted with a flexible material that couples the HIFU therapy transducer to the probe and allows the transducer to be drawn to the side of the probe for insertion. In another implementation, a probe may have one or more inflatable bladders that form the HIFU therapy transducer. In yet another implementation, a probe may have an imaging component and a HIFU therapy transducer disposed thereon that rotate, as a unit, about a hinge.

CROSS-REFERENCE TO RELATED APPLICATION

This application claims the benefit of U.S. Provisional Application No.60/758,797, titled TRANSVAGINAL IMAGE-GUIDED HIGH INTENSITY FOCUSEDULTRASOUND (HIFU) DEVICES AND METHODS FOR THERAPY TO THE FEMALEREPRODUCTIVE SYSTEM, filed Jan. 13, 2006.

FIELD OF THE INVENTION

The present application is directed to apparatus that providetherapeutic treatment of internal pathological conditions usinghigh-intensity focused ultrasound energy, and more particularly, toproviding improved apparatus for insertion and deployment of a HIFUtherapy transducer, with or without an imaging component.

BACKGROUND

Delivery of high-intensity focused ultrasound (HIFU) energy has emergedas a precise, non-surgical, minimally-invasive treatment for benign andmalignant tumors. (See, e.g., S. Vaezy, M. Andrew, P. Kaczkowski et al.,“Image-guided acoustic therapy,” Annu. Rev. Biomed. Eng. 3, 375-90(2001)). At focal intensities 4-5 orders of magnitude greater thandiagnostic ultrasound (typically about 0.1 W/cm²), HIFU (typically about1000-10,000 W/cm²) can induce lesions or tissue necrosis at a smalllocation deep in tissue while leaving tissue between the ultrasoundsource and focus unharmed. Tissue necrosis is a result of focaltemperatures typically exceeding 70° C. which can occur with relativelyshort intervals of HIFU exposure. HIFU is currently being usedclinically for the treatment of prostate cancer and benign prostatichyperplasia, as well as malignant bone tumor and soft tissue sarcoma.Clinical trials for HIFU treatment of breast fibroadenomas and variousstage 4 primary and metastatic cancer tumors of the kidney and liver areunderway.

Uterine fibroid, as an example of a pathological condition in the femalepelvis, is the most common pelvic tumor in women of reproductive age.Uterine fibroids, or leiomyoma, are benign tumors that cause abnormaluterine bleeding. The incidence of fibroids has been estimated to be20-25% in women in their reproductive years, although autopsy studiesshow an incidence upwards of 75%. Approximately ⅓ of these women willhave a tumor that is symptomatic requiring treatment. HIFU energydelivered using a transvaginal transducer can provide a feasiblyminimally-invasive treatment for uterine fibroids.

Further development of HIFU devices for providing therapy in obstetricsand gynecology, as well as other fields of medical endeavor, is desired.In particular, improved devices are needed which can provide noninvasivetherapeutic treatment of uterine fibroids, recurrent leiomyosarcoma, andother solid tumors of the uterine corpus and cervix, as well as abnormaluterine bleeding conditions and many other obstetric and gynecologicpathological conditions.

A major challenge for transvaginal HIFU treatment of uterine pathologiesis the deployment of a HIFU therapy transducer having an aperture ofadequate size. In general, devices with a larger HIFU aperture tend tooptimize the focal length of the HIFU beam and the therapeutic effect ofthe focused ultrasound energy. However, the size and configuration ofthe HIFU aperture are generally limited by the size and shape of thevaginal cavity and the location of the cervix and vaginal fornices.

Even more challenging is the issue of transvaginal insertion of a HIFUtherapy transducer through the rather narrow vaginal introitus. Thepresent application addresses the problems of insertion of a probe witha HIFU transducer through small passages, such as the vaginal introitus,and deployment of the HIFU transducer, with or without an imagingcomponent, within a body cavity in order to achieve optimal imaging andHIFU therapeutic effects.

BRIEF SUMMARY

The following description briefly summarizes certain aspects of thedisclosure herein. This summary is not intended to identify all featuresor implementations disclosed herein, nor is it intended to identify keyfeatures or otherwise be used to define the scope of the inventionclaimed hereafter.

In one implementation, an apparatus for delivering high intensityfocused ultrasound (HIFU) energy to a treatment site internal to apatient's body may include an elongate probe with a HIFU therapytransducer coupled thereto. The HIFU therapy transducer is comprised ofa plurality of leaves, each leaf having a front surface adapted todirect HIFU energy to a treatment site when the probe is inserted in apatient's body and a deployment mechanism is activated. When activated,the deployment mechanism is configured to deploy the leaves by directingthe leaves in a radially outward direction. The leaves thus deployedcollectively provide a bowl-shaped HIFU therapy transducer having anouter edge with a diameter that is larger than the diameter of theprobe. To facilitate insertion of the probe in the patient's body, theplurality of leaves are configured to collapse when the deploymentmechanism is not activated. The collapsed leaves occupy a space having adiameter smaller than the diameter of the outer edge of the HIFU therapytransducer when the leaves are deployed.

In one aspect, the probe may include a sleeve disposed around a shaft.The shaft is configured to slide within the sleeve from a retractedposition to an extended position. Each leaf is coupled to a distal endof the shaft, and the deployment mechanism includes a pin coupled to thesleeve that slides within a groove defined in each leaf. Activation ofthe deployment mechanism comprises sliding the shaft within the sleevetoward the extended position, which causes each leaf to be pushedoutward from the distal end of the sleeve. As the pin slides within thegroove in each respective leaf, the distal end of the leaf is directedradially outward to a desired position to provide the bowl-shaped HIFUtransducer. An actuator, such as a button connected to the shaft, may beconfigured to help drive the shaft between the retracted and extendedpositions.

In another aspect, each leaf may be coupled to a distal end of thesleeve, wherein the deployment mechanism of each leaf includes a spinecoupled to the shaft. The spines are configured to slide within thesleeve into a channel defined in the leaf. Activation of the deploymentmechanism comprises sliding the shaft within the sleeve toward theextended position, thus causing the spine for each leaf to be pushedinto the channel of the respective leaf which directs the leaf radiallyoutward. When the spines are retracted in the sleeve and the leaves arecollapsed, the leaves are capable of being grouped together to occupy aspace having a diameter that is equal to or smaller than the diameter ofthe sleeve.

In another aspect, the proximal end of each leaf may be coupled to adistal end of the shaft, wherein the deployment mechanism includes aspring having a first end coupled to the shaft and a second end disposedwithin the leaf. Activation of the deployment mechanism comprisessliding the shaft within the sleeve toward the extended position. Aseach leaf is pushed outward from the sleeve, the second end of thespring in each leaf biases the distal end of the leaf in a radiallyoutward direction to provide the bowl-shaped HIFU transducer.

In another aspect, a portion of each leaf may be formed of anenergy-activated shape memory alloy. The deployment mechanism includes acoupling of the shape memory alloy to an energy source. Activation ofthe deployment mechanism comprises delivering energy from the energysource to the shape memory alloy of each leaf to cause the shape memoryalloy to take a predefined shape in which the distal end of the leavesare directed radially outward to provide the bowl-shaped HIFUtransducer. The portion of the leaves formed of a shape memory alloy maybe configured as a spine in each leaf.

The HIFU therapy transducer may also be coupled to the probe via ahinge, enabling the HIFU transducer to rotate about the hinge to helpaim the HIFU energy toward the treatment site.

In another implementation, an apparatus for HIFU energy to a treatmentsite internal to a patient's body may include an elongate probe fittedwith a flexible material that couples a HIFU therapy transducer to theprobe. For reference purposes, the HIFU therapy transducer may beconsidered as having a major axis across its face. In a resting state,the flexible material deploys the transducer in a therapy positionwherein the major axis of the transducer is non-parallel to thelongitudinal axis of the probe. To facilitate insertion of the probe inthe patient's body, the flexible material is configured to stretch andallow the transducer to be drawn to the side of the probe to aninsertion position where the major axis of the transducer is generallyparallel to the longitudinal axis of the probe. After insertion, thetransducer is released and the flexible material returns toward itsresting state, thus deploying the transducer for therapy delivery. Ifdesired, an actuator may be coupled to the transducer and manipulated todraw the transducer to the side of the probe for insertion and/orremoval of the probe from the patient. The actuator may also bemanipulated to deploy the transducer for therapy delivery after theprobe has been inserted into the patient.

In another implementation, an apparatus for delivering HIFU energy to atreatment site internal to a patient's body may include an elongateprobe fitted with a flexible material that has one or more inflatablebladders. The bladders extend radially outward from the distal end ofthe probe. When inflated, the bladders form a HIFU therapy transducerhaving an aperture that is larger than the diameter of the probe. Thebladders are not inflated until after the probe is inserted in thepatient's body. When not inflated, the bladders occupy a space having adiameter smaller than the diameter of the HIFU therapy transducer whenotherwise inflated. The flexible material is configured with a frontsurface that is adapted to direct HIFU energy to the treatment site whenthe bladders are inflated.

In one aspect, the bladders may comprise one or more inflatable channelsthat extend radially outward from the distal end of the probe, whereinthe front face of the flexible material extends between the inflatablechannels. The inflatable channels may terminate in an inflatable ringthat forms an outer edge of the HIFU therapy transducer. When inflated,the diameter of the ring is larger than the diameter of the probe.

In another implementation, an apparatus for delivering image-guided HIFUenergy to a treatment site internal to a patient's body may include aprobe with a support structure having an imaging component and a HIFUtherapy transducer disposed thereon. A hinge is used to connect thesupport structure to the distal end of the probe. The imaging componentis preferably adapted for producing an image of a portion of thepatient's body that includes the treatment site, while the HIFU therapytransducer directs HIFU energy to the treatment site. The HIFU therapytransducer is disposed on the support structure in defined relation tothe imaging component.

To facilitate insertion of the probe in a patient's body, the supportstructure is capable of rotating about the hinge to a position generallyparallel to the longitudinal axis of the probe. After insertion of theprobe, the support structure is capable of rotating about the hinge to aposition non-parallel to the longitudinal axis of the probe. The hingethus provides an articulation that enables the imaging and therapytransducers as a unit to be positioned relative to the treatment site inthe patient's body.

In one aspect, the HIFU therapy transducer may be bowl-shaped, with theimaging component disposed in the interior of the therapy transducer. Inanother aspect, the imaging component may be disposed on the supportstructure to the exterior of the HIFU therapy transducer.

In the foregoing implementations, an imaging component included with theprobe may be configured to use reflected ultrasound energy to produce animage of a portion of the patient's body. Alternatively, or in addition,the imaging component may be configured to use reflected light toproduce an image of a portion of the patient's body. Still anotheralternative is that the imaging component consists of the sametransducer as used to produce the HIFU energy. In some cases, the imageproduced by the imaging component may include a portion of the HIFUtherapy transducer and/or the focal point of the HIFU energy within thetissue. The image obtained by the imaging component may assist inpositioning the HIFU therapy transducer within the patient's body and inmonitoring the delivery and effects of the HIFU therapy at the treatmentsite.

DESCRIPTION OF THE DRAWINGS

The foregoing aspects and many of the attendant advantages of thisinvention will become more readily appreciated as the same become betterunderstood by reference to the following detailed description, whentaken in conjunction with the accompanying drawings, wherein thedrawings are described as follows:

FIG. 1 illustrates in section view a possible environment in which animplementation of the present invention may be used for treatment ofpathologies of the female reproductive system;

FIG. 2 illustrates the implementation of the apparatus depicted in FIG.1;

FIGS. 3A-3C illustrate an implementation of the invention having aretractable HIFU therapy transducer;

FIG. 4 illustrates a side section view of the implementation shown inFIGS. 3A-3C;

FIGS. 5A and 5B illustrate an implementation of the invention with acollapsible HIFU therapy transducer;

FIGS. 6A and 6B illustrate an implementation of the invention with aflexible material coupling a HIFU therapy transducer to a probe;

FIGS. 7A and 7B illustrate an implementation of the invention having aHIFU therapy transducer with an inflatable support;

FIG. 8 illustrates another implementation of a probe having a HIFUtherapy transducer with an inflatable support;

FIGS. 9A and 9B illustrate further aspects of an implementation of theinvention with an imaging component and HIFU therapy transducer as aunit configured to rotate about a hinge, where the imaging component isdisposed within the interior of the HIFU therapy transducer; and

FIGS. 10A and 10B illustrate further aspects of an implementation of theinvention similar to the implementation shown in FIGS. 9A and 9B, wherethe imaging component is disposed to the exterior of the HIFU therapytransducer.

DETAILED DESCRIPTION

Disclosed herein are implementations of an apparatus designed fordelivering high-intensity focused ultrasound (HIFU) energy to atreatment site internal to a patient's body. The implementations hereinfacilitate the insertion of a probe with a HIFU therapy transducerthrough a narrow opening to various cavities of the human body. Theseimplementations can be applied to body orifices and cavities including,but not limited to, the urinary tract, gastrointestinal tract,cardiovascular system, respiratory system, and reproductive system, aswell as through endoscopes or laparoscopes for minimally-invasivesurgery in various parts of the body. For purposes of illustrationherein, various implementations are shown and discussed in the contextof providing HIFU therapy in the female reproductive system.

FIG. 1 illustrates an implementation of the invention, wherein a probe 1with a HIFU therapy transducer 2 has been introduced into the vaginalcavity of a female patient 3. In this particular implementation, theHIFU therapy transducer is designed for coupling to the uterine cervixfor delivering a highly focused beam of HIFU energy, depicted by dottedline, to a treatment site within the uterus. In this illustration, thetreatment site is a uterine fibroid 4. By mating against the cervix, theHIFU therapy transducer 2 is able to direct ultrasound emissions thatare limited to the uterine tissue, thereby enhancing the therapeutic,and possibly diagnostic, effects of the ultrasound energy by emittingthe energy through a constant uterine tissue medium.

An additional coupling device can be used between the transducer 2 andthe cervix to optimize the ultrasound transmission. The coupling mayfurther include a cooling component. Known in the art are variouspillows filled with fluid that can provide a cooled coupling between aHIFU transducer and a mass of tissue. The probe 1, shown in FIG. 1,further includes a coupling 5 to an external source that may deliver acirculation of cooling fluid, as well as energy to the probe 1 foroperating the components of the probe. The cooling fluid is used tolower the temperature of the HIFU transducer as well as the tissuesurrounding the transducer, including but not limited to the cervix, todecrease the risk of collateral thermal damage from the focused HIFUbeam. The coupling of the transducer 2 to the cervix further enables theclinician to manipulate the position of the cervix and uterus tooptimize the HIFU treatment.

As will be discussed with respect to the remaining figures,implementations of the invention are configured with a HIFU therapytransducer having a compact state for insertion into the vaginal cavity,after which the HIFU therapy transducer is deployed to a larger state inwhich the transducer can deliver HIFU therapy to target tissue in thebody.

If desired, the probe 1 may further include an imaging component that isoperable to visualize the various pelvic organs and pathologies. Theimaging component may be designed to produce two-dimensional orthree-dimensional visual images of the tissue of interest and/or bloodflow of the tissue, as well as provide a temperature quantification ofthe tissue in view. Further, while the imaging system may be designed touse ultrasound energy, imaging technologies are not limited to such anenergy modality.

As depicted, the therapeutic component of the HIFU transducer may beconstructed with various configurations to achieve optimal focal lengthand aperture sizes and shapes to achieve an optimal energy delivery fortherapeutic purposes. Implementations of the invention can beconstructed, as described herein, to provide optimal energy delivery tointended targets, such as fibroid tumors in the uterus, while alsoaddressing the issue of limiting any collateral damage to adjacenttissue. Furthermore, by managing the harmonics of transducer excitation,as well as the phase and direction of energy emission, the shape andlocation of the focal point of the HIFU transmission can be adjusted.

Elements for generating HIFU energy are well known in the art. A HIFUtransducer may be configured with HIFU-generating element arranged in anannular array, for example, which may allows focal range control.Alternatively, the HIFU generating elements may be arranged in a lineararray, which may allows both focal range and steering control. In yetother implementations, the elements could be arranged in atwo-dimensional array, which may allows focal range and steering controlin three dimensions. The latter arrangement is preferably used inconcert with a two-dimensional imaging array that allows forthree-dimensional ultrasound visualization. Where multiple elements areused, the elements may be phased with varying phase to allow properfocusing of the HIFU transducer on various targets in the body.Alternatively, HIFU emission from the multiple elements may becoordinated to produce a beam as if coming from a single element.

An apparatus for delivering HIFU energy constructed in accordance withan implementation of the present invention, as shown in FIG. 1, is shownin greater detail in FIG. 2. The apparatus includes an elongate probe 10having a proximal end 12 and a distal end 14. The proximal end 12 of theprobe 10 preferably has a section adapted for positioning the distal end14 at a desired location within a body cavity when the probe 10 isinserted through an orifice into the patient's body. In thisimplementation, the distal end 14 of the probe 10 has a HIFU therapytransducer 16 coupled thereto. The HIFU therapy transducer 16 comprisesa plurality of leaves 18. Each leaf 18, as shown, has a proximal end 20and a distal end 22, as well as a deployment mechanism that will bediscussed in greater detail below. The proximal end 20 of each leaf 18is coupled to the distal end 14 of the probe 10.

Each leaf 18 has a front surface 24 adapted to direct HIFU energy to atreatment site in the patient's body when the HIFU therapy transducer 16is deployed. In the implementation shown in FIG. 2, the front surface 24of at least one of the leaves includes an active element 26 disposedthereon. The active element 26 is operable to generate HIFU energy thatis directed by the transducer 16 to the treatment site, such as thefibroid shown in FIG. 1. HIFU-generating elements, as well as thesignals and systems required for operating the active elements togenerate HIFU energy, are well known in the art and need not bediscussed in detail herein. For example, HIFU elements usingpiezoelectric technologies are known in the art and may be used in theimplementations discussed herein.

Depending on the materials used to construct the leaves 18 and thedimension of the leaves 18 in the HIFU therapy transducer 16, the leaves18 may each be independently coupled to the probe 10, separate from oneanother. For stability of the transducer 16, the leaves 18 may also beinterconnected to each other if desired. In FIG. 2, the leaves 18 areconstructed to collapse to a smaller state by sliding over the top ofone another, thus reducing the dimension of the HIFU therapy transducerfrom a deployed state, as shown in FIG. 2, to a more compact state thatfacilitates insertion of the probe 10 into a body cavity.

Each of the leaves 18 has a deployment mechanism that is used to deploythe HIFU therapy transducer 16 to a state as shown in FIG. 2 after theprobe 10 is inserted into the patient. When activated, the deploymentmechanism is configured to deploy the leaves 18 by directing the distalend 22 of the leaves 18 in a radially outward direction. The leaves,thus deployed, collectively provide a bowl-shaped HIFU therapytransducer 16 having an outer edge 28 with a diameter that is largerthan the diameter of the probe 10. The HIFU therapy transducer 16, whendeployed, has an aperture of a size sufficient to direct a highlyfocused beam of HIFU energy to a treatment site in a patient. When thedeployment mechanism is not activated, the collapsed leaves 18 occupy aspace having a diameter smaller than the diameter of the outer edge 28of the transducer 16 when the leaves 18 are deployed.

In the implementation shown in FIG. 2, as well as certain otherimplementations disclosed herein, the probe 10 includes a sleeve 30disposed around a shaft 32. The sleeve 30 has a proximal end 34, adistal end 36, and a longitudinal axis extending therebetween. The shaft32 is configured to slide within the sleeve 30 from a retracted positionto an extended position along the longitudinal axis of the probe 10.

To assist the sliding of the shaft from the retracted to the extendedposition, an actuator, such as a button 38, may be provided. In FIG. 2,the button 38 is connected to the shaft 32 and slides within a groove 40in the sleeve 30. A clinician operating the probe may grasp the button38 and slide it within the groove 40 to the position shown in FIG. 2 toplace the shaft in the extended position.

When the button 38 is slid through the groove 40 toward the proximal end34 of the probe, the shaft 32 is pulled within the sleeve 30. As theshaft 32 is sliding inward, the leaves 18 contact the distal end 36 ofthe sleeve 30 and inwardly contract to be pulled within the sleeve 30.In the implementation shown, a portion of each leaf 18 is designed toslide over in front of an adjacent leaf 18 as the shaft 32 is pulledwithin the sleeve 30 and the leaves 18 contract.

FIG. 2 additionally illustrates a hinge 42 at the distal end 14 of theprobe 10. In this implementation, the HIFU therapy transducer 16 iscoupled to the distal end 14 of the probe 10 via the hinge 42. The hinge42 has an axis about which the transducer 16 can rotate to aim the HIFUenergy toward the treatment site in the patient's body, e.g., asdepicted in FIG. 1.

FIGS. 3A-3C illustrate an implementation of an elongate probe 50 havinga HIFU therapy transducer 52 comprised of retractable leaves 54, similarto the probe 10 shown in FIGS. 1 and 2. The probe 50 includes a sleeve56 disposed around a shaft 70 (FIG. 4) inside the sleeve. The sleeve 56has a proximal end 58, a distal end 60, and a longitudinal axis 62extending therebetween. The shaft is configured to slide inside thesleeve 56 from a retracted position, as shown in FIG. 3A, to an extendedposition, as shown in FIG. 3C, along the longitudinal axis 62. FIG. 3Billustrates the shaft at an intermediate stage between the retracted andextended positions.

As with the implementation shown in FIGS. 1 and 2, each leaf 54 has afront surface 64 adapted to direct HIFU energy to a treatment site whenthe probe 50 is inserted into a patient's body. An active element 66disposed on the front surface 64 is operable to generate the HIFU energythat is directed to the treatment site. Although the implementation inFIGS. 3A-3C depicts multiple leaves 54 having a front surface 64 with anactive element 66, not all of the leaves 54 are required to have anactive element. Indeed, in at least some implementations, the frontsurface 64 may be designed without any active elements for generatingHIFU energy. Instead, the front surface 64 of at least one of the leaves54 is configured to reflect HIFU energy toward the treatment site,wherein the HIFU energy is received from a source that is remote fromthe leaf. For example, a HIFU energy source may be coupled to the probeat a location central to the HIFU therapy transducer 52 but away fromthe leaves 54. Alternatively, a HIFU energy source may be locatedseparate from the probe 50. In either case, the front surface 64 of atleast one of the leaves 54 is provided with a mirror-like material thatreflects HIFU energy incident upon the surface 64. Materials withproperties known for reflecting incident energy are readily availableand recognized by persons having ordinary skill. The geometry of theleaves 54, when in a deployed state, is configured to direct the HIFUenergy to a focal point at the intended treatment site in the patient.

FIG. 4 illustrates a side section view of the probe 50 shown in FIG. 3B.In FIG. 4, the sleeve 56 is shown disposed around the shaft 70. Each ofthe leaves 54 has a proximal end 72 and a distal end 74. The proximalend 72 of each leaf 54 is coupled to a distal end 76 of the shaft 70,e.g., through a pin, adhesive, welding, or the like. Where the leaf 54includes an active HIFU-generating element, the coupling furtherincludes a means for conveying energy from the probe 50 to the activeelement, such as a wire.

Each leaf 54 further includes a deployment mechanism that, whenactivated, deploys the leaves 54 by directing the distal end 72 of theleaves in a radially outward direction. In the implementation shown inFIGS. 3A-3C and in FIG. 4, the deployment mechanism of each leafincludes a pin 78 that is coupled to the distal end 60 of the sleeve 56.The pin 78 is configured to slide within a groove 80 (FIGS. 3B and 3C)defined in the leaves 54.

Activation of the deployment mechanism in this implementation comprisessliding the shaft 70 within the sleeve 56 toward the extended positionshown in FIG. 3C. As the shaft 70 slides upward through the sleeve 56,each leaf 54 is pushed outward from the distal end 60 of the sleeve 56.As each leaf is pushed outward, the pin 78 for each respective leaf 54slides within the groove 80 to direct the distal end 74 of the leafradially outward to a desired position in which the leaves collectivelyprovide a bowl-shaped HIFU transducer 52, as shown in FIG. 3C.

In the illustrated implementation, the grooves 80 are defined at anangle relative to the longitudinal axis 62 such that the leaves 54 aredirected sideways, as well as outward, when the shaft 70 is slid to theextended position. Similarly, when the shaft 70 is drawn to theretracted position shown in FIG. 3A, the pin 78 for each leaf 54 slideswithin the groove 80 to guide the leaf laterally and radially inward asthe leaves are pulled into the sleeve 56. As depicted in FIG. 3B, atleast a portion of a leaf 54 in the plurality of leaves is configured tooverlap at least a portion of another leaf 54 when the leaves areretracted and held within the sleeve 56. To assist with retracting orextending the shaft 70, an actuator, such as a button 82, may beattached to the shaft 70, as shown in FIGS. 3A-3C. As with theimplementation shown in FIGS. 1 and 2, the button 82 may slide within agroove 84 defined in the sleeve 56. A force exerted on the button 82 ina direction toward or away from the distal end 60 of the sleeve 56 istranslated to the shaft 70 for moving the shaft 70 within the sleeve.

If desired, the pin 78 may include a detent that is configured to securethe pin within the groove 80 in each respective leaf. Furthermore, ifdesired, the probe 50 may be configured such that the distal end 76 ofthe shaft 70 extends beyond the distal end 60 of the sleeve 56 when theshaft is in the extended position, thus exposing the distal end 76 ofthe shaft 70 outside the sleeve 56. This latter feature may beadvantageous when the probe 50 is configured with an imaging component86 at the distal end 76 of the shaft 70. Coupling an imaging component86 to the distal end of the shaft, or otherwise to the distal end of theprobe, may assist in the process of delivering HIFU therapy to thepatient.

The imaging component 86 is preferably adapted to produce an image of aportion of the patient's body that includes the treatment site receivingthe HIFU energy. Conventional imaging technologies may be used. Theimage may help guide the delivery of HIFU energy to the treatment site.In one aspect, the imaging component may be configured to use reflectedultrasound energy to produce the image of the portion of the patient'sbody. Diagnostic ultrasound uses ultrasound energy at a much lower powerdensity so as not to damage tissue. Reflected ultrasound energy canmeasure tissue forms and densities at various depths in the patient'sbody.

Alternatively, the imaging component 86 may be configured to usereflected light to produce a visual image of a portion of the patient'sbody. Light-based imaging technologies may include elements such asfiber optic transmission and reception of light, lenses (as needed),and/or electronic charge-coupled devices (CCDs) that can receive andmeasure reflected light to produce an image.

Where reflected ultrasound energy is used to produce an image, theemission and reception of diagnostic ultrasound energy should besynchronized with the transmission of HIFU energy so as not to obscurethe image obtained by the imaging component 86. Technologies forsynchronizing imaging and HIFU pulses are available in the art. See,e.g., U.S. patent application Publication No. 2006/0264748, titled“Interference-Free Ultrasound Imaging During HIFU Therapy, UsingSoftware Tools,” by Shahram Vaezy et al., the disclosure of which isincorporated by reference herein.

Additionally, imaging technologies may be used to provide real-timetwo-dimensional or three-dimensional viewing of the target site, as wellas blood flow color imaging (Doppler) and temperature changequantifications of the target tissue, using ultrasound back scatterinformation obtained from either the HIFU transducer or the imagingcomponent.

FIGS. 5A and 5B illustrate an implementation of a probe 100 withfeatures similar to those shown and described with respect to FIGS. 1-4,including a plurality of leaves 102 that can be deployed to collectivelyprovide a bowl-shaped HIFU transducer 104. As with the previouslydescribed implementations, the probe 100 further includes a sleeve 106disposed around a shaft within the sleeve. An actuator, such as thebutton 108, is connected to the shaft to assist in sliding the shaftfrom a retracted position, as shown in FIG. 5A, to an extended position,as shown in FIG. 5B.

In contrast to the previously described implementation, the leaves 102are coupled to the sleeve 106. More specifically, each leaf 102 has aproximal end 110 and a distal end 112. The proximal end 110 of each leafis coupled to the distal end 114 of the sleeve 106. Furthermore, theproximal end 116 of the sleeve 104 may have a section adapted forpositioning the distal end 114 at a desired location within a patient'sbody when the probe 100 is inserted into the patient.

As further depicted in dotted line in FIG. 5A, a plurality of spines 118may be coupled to the distal end 120 of the shaft within the sleeve 106.When the shaft is in the retracted position, as shown in FIG. 5A, thespines 118 are held within the sleeve 106. The leaves 102 areconstructed such that they can overlap one another in a collapsedconfiguration as shown, where the leaves 102 are capable of beinggrouped together to occupy a smaller space. For example, as shown inFIG. 5A, the group of leaves 102 may occupy a space having a diameterthat is equal to or smaller than the diameter of the sleeve 106. Havingthe leaves in a collapsed state facilitates insertion of the probe 100into a patient's body. After the probe 100 is inserted into the intendedcavity of a patient's body, the leaves 102 may be deployed using adeployment mechanism, namely, the spines 118, to direct the distal end112 of each leaf in a radially outward direction to a desired positionto provide the bowl-shaped HIFU transducer 104.

Thus, in operation, activation of the deployment mechanism for FIGS. 5Aand 5B comprises sliding the shaft within the sleeve 106 toward theextended position, as depicted in FIG. 5B. As the shaft is slid withinthe sleeve, the spines 118 emerge from the sleeve 106 and slide withingrooves 122 defined in each of the leaves 102. As the spines 118progressively enter the grooves 122, the spines 118 direct the distalend 112 of each of the leaves 102 in a radially outward direction. Thespines 118 also provide support to the leaves 102 when the plurality ofleaves are deployed. Pulling the shaft into the sleeve 106 toward theretracted position withdraws the spines 118 from the grooves 122, whichallows the leaves 102 to collapse to the state shown in FIG. 5A.

The spines 118 may be constructed of a suitable material capable ofproviding support to the leaves 102 when the shaft is extended and theleaves are deployed. The spines 118 may be configured to exert anoutwardly directed bias force on the leaves 102 when the shaft isextended and the spines 118 fill the grooves 122. The spines 118 areconstructed to hold the leaves 104 in the deployed state, as shown inFIG. 5B. If desired, one or more stops may be defined in the distal end114 of the sleeve 106 to engage the leaves 102 once the leaves havereached the deployed position. The outwardly-directed bias force of thespines 118 may derive from a natural characteristic of the materialsused to construct the spines, such as a spine formed of a materialhaving an outwardly-directed curve in a resting state outside the sleeve106, which is flexible to bend to a straight non-resting state insidethe sleeve 106. Alternatively, a mechanism, such as a spring, may beconfigured with the spines 118 to bear against the spines 118 and directthe leaves in a radially outward direction when deployed.

In another alternative implementation, a deployment mechanism comprisedof springs having a first end coupled to the shaft and a second enddisposed within the leaf, may be used. An implementation using springsfor deployment may be visualized using the drawings in FIGS. 3A-3C,wherein the grooves 80 are filled with the second end of a spring, asdescribed, instead of being guided by pins 78 in the sleeve 56. In thiscase, the second end of the springs need not be disposed at an angle asthe grooves 80 are depicted. As the shaft within the sleeve 56 is slidupward to an extended position, as shown in FIG. 3C, the second end ofthe springs emerges from the sleeve 56 and exerts an outward bias todirect the distal end of the leaves 54 in a radially outward direction.Similarly, retracting the shaft within the sleeve 56 pulls the leaves 54with the springs into the sleeve 56, wherein the leaves and springs areheld, as shown in FIG. 3A.

In yet another implementation, a portion of the leaves, such as theleaves 102 shown in FIG. 5B, may be formed of an energy-activated shapememory alloy. The deployment mechanism of the leaves 102 in thisimplementation includes a coupling that connects the shape memory alloyto an energy source. Activation of the deployment mechanism comprisesdelivering energy from the energy source to the shape memory alloy ineach leaf that causes the shape memory alloy to take a predefined shapein which the distal end of the leaves 102 are directed radially outwardto provide a bowl-shaped HIFU transducer 104.

A typical shape memory alloy is made of nickel and titanium and is knownfor its flexibility as well as shape changing properties. The alloydynamically changes its internal structure at certain temperatures.Structures formed with a shape memory alloy, such as the leaves 102, canbe deformed at room temperature, and when the shape member alloy isheated, the alloy causes the structure to shift to a predefined shape.For example, shape memory alloys may contract when heated and then beeasily stretched out again as they return to their original temperature.Energy-driven heating and cooling of a shape memory alloy can beaccomplished quite quickly.

In the context of the present invention, a probe, such as the probe 100shown in FIG. 5B (without spines 118 shown in FIG. 5A), may include aplurality of leaves 102 having a proximal end 110 coupled to the probe.Some or all of each leaf 102 may be formed of a shape memory alloy. Asenergy from an energy source within the probe is delivered to the shapememory alloy of the leaves, the leaves flex in a radially outwarddirection to provide the HIFU therapy transducer 104, as shown. In animplementation where spines 118 are used, the spines may be formed of ashape memory alloy which, being activated by the application of energyto the alloy, cause each of the spines 118 to flex in a radially outwarddirection, thus placing the leaves 102 in a deployed state. In suchimplementations, the spines 118 may or may not retract within grooves122, as shown in FIG. 5A. Where the spines 118 do not retract, theleaves 102 are still capable of collapsing into a group, as shown inFIG. 5A, when the shape memory alloy of the spines 118 is not activatedby the energy source.

Turning now to FIGS. 6A and 6B, another implementation constructed inaccordance with the present invention comprises an elongate probe 130having a proximal end 132, a distal end 134, and a longitudinal axis 136extending therebetween. As with other implementations herein, theproximal end 132 of the probe 130 may have a section adapted forpositioning the distal end 134 of the probe at a desired location withina patient's body when the probe 130 is inserted into the patient.

The distal end 134 of the probe 130 is fitted with a flexible material138 that couples a HIFU therapy transducer 140 to the probe 130. TheHIFU therapy transducer 140 has an aperture of a size sufficient todirect therapeutic HIFU energy to a treatment site in the patient. Forreference purposes, the HIFU therapy transducer 140 has a major axis 142extending across its face.

In a resting state, as shown in FIG. 6B, the flexible material 138couples the transducer 140 to the probe 130 in a therapy positionwherein the major axis 142 of the transducer is non-parallel to thelongitudinal axis 136 of the probe. To facilitate insertion of the probe130 in a patient's body, e.g., through the vaginal introitus, theflexible material 138 is configured to stretch and allow the transducer140 to be drawn to the side of the probe 130 to an insertion position asshown in FIG. 6A. In the insertion position, the major axis 142 of thetransducer 140 is generally parallel to the longitudinal axis 136 of theprobe 130. This allows the largest dimension of the transducer 140 to bein the sagittal axis of the vaginal introitus. The flexible material138, thus stretched, exhibits a bias to return toward its resting stateas shown in FIG. 6B. After the probe 130 has been inserted into theintended cavity of a patient's body, such as the vaginal cavity, thetransducer 140 is released from the insertion position and allowed toreturn to the therapy position shown in FIG. 6B.

If desired, an actuator may be coupled to the HIFU therapy transducer140 to draw the transducer 140 to the side of the probe 130 while theprobe is either being inserted into the patient or withdrawn from thepatient. The actuator may also be manipulated to deploy the transducer140 to the therapy position shown in FIG. 6B. Suitable actuatorsinclude, but are not limited to, a cable and/or a latch that can pull,push, and/or hold the transducer in an insertion position as shown inFIG. 6A or in a therapy position as shown in FIG. 6B. In at least oneimplementation, manipulating the actuator to deploy the transducer 140may simply involve releasing the transducer and allowing the flexiblematerial 138 to place the transducer in a therapy position. In anotherimplementation, the actuator may actively move the transducer 140 to thedesired therapy position.

As with other implementations previously described, the distal end 134of the probe 130 may include an imaging component 144 adapted forproducing an image of a portion of the patient's body when the probe 130has been inserted in the patient. Preferably, the image produced by theimaging component includes the treatment site receiving the HIFU energyfrom the transducer 140 to help guide the delivery of the HIFU energy tothe treatment site. In one implementation, the imaging component may beconfigured to use reflected ultrasound energy to produce the image ofthe portion of the patient's body. In an alternative implementation, theimaging component may be configured to use reflected light to producethe image. In either case, the image produced by the imaging componentmay further include a portion of the HIFU therapy transducer 140 toassist in positioning the transducer 140 within the patient's body andin monitoring the HIFU therapy occurring at the treatment site.

In a suitable implementation, the flexible material 138 may be comprisedof a resilient, non-metal material, such as a medical grade plastic,rubber, or silicon. In an alternative implementation, the flexiblematerial 138 may be comprised of a shape memory alloy having a stretchedstate or resting state dependent on energy activation of the alloy. Theshape memory alloy may be activated to assume a predefined shape basedon energy supplied to the alloy which typically heats the alloy andcauses the change in shape. Details regarding the structure and use ofshape memory alloys have been discussed earlier herein.

Also, as with earlier described implementations, an active element 146may be disposed on the HIFU therapy transducer 140, wherein the activecomponent is operable to generate the HIFU energy that the transducer140 directs to the treatment site. Alternatively, the HIFU therapytransducer 140 may be configured with a surface that reflects HIFUenergy toward the treatment site. The HIFU energy in this latterimplementation may be received from a source that is remote from thetransducer 140. Materials, such as a reflective Mylar, capable ofreflecting ultrasound energy that is incident thereon, are known in theart.

In yet another implementation of an apparatus constructed according tothe present invention, a probe 160, as shown in FIGS. 7A and 7B, may beused to treat pathologies in a patient's body. To facilitate insertionof the probe 160 in the patient, the probe 160 is configured with a HIFUtherapy transducer formed of one or more inflatable bladders.

As with prior implementations, the elongate probe 160 has a proximal end164 and a distal end 166. The proximal end 164 preferably has a sectionadapted for positioning the distal end 166 of the probe at a desiredlocation when the probe 160 is inserted into a patient's body. Thedistal end 166 of the probe 160 is fitted with a flexible materialhaving one or more inflatable bladders that, when inflated, provide theHIFU therapy transducer 162. The transducer 162 has an aperture of asize sufficient to direct a focused beam of therapeutic HIFU energy to atreatment site in a patient. The inflatable bladders may be constructedof an expandable material, such as (but not limited to) rubber orsilicon.

The one or more inflatable bladders 168 extend radially outward from thedistal end 166 of the probe 160. The bladders 168 are not inflated untilafter the probe is inserted into the intended cavity of the patient'sbody, such as through the vaginal introitus into the vaginal cavity.After insertion, the bladders 168 are inflated to form and providelateral support to the HIFU therapy transducer 162 within the patient'sbody. When inflated, the transducer 162 has an aperture that is largerthan the diameter of the probe 160. Appropriate conduits for deliveringa pressurized fluid, such as a liquid or gas, to the inflatable bladders168 are provided within the probe 160 and coupled to the bladders 168.Likewise, conduits are provided to conduct the fluid away from thebladders 168 when the bladders are deflated. If desired, the fluid(liquid or gas) may be circulated to and from the bladders 168 andcooled to help manage the temperature of the transducer 162 and/ortissue adjacent to the transducer 162 when HIFU therapy is beingapplied.

As further depicted in FIG. 7B, the flexible material forming the HIFUtherapy transducer 162 has a front surface 170 adapted to direct HIFUenergy to the treatment site in the patient when the probe 160 isinserted and the bladders 168 are inflated.

In the implementation illustrated in FIGS. 7A and 7B, the bladders 168comprise one or more inflatable channels that extend radially outwardfrom the distal end 166 of the probe 160. The front face 170 of theflexible material extends between the inflatable channels 168.

If desired, the inflatable channels 168 may terminate in an inflatablering 172 that forms an outer edge 174 of the HIFU therapy transducer162. The ring 170, when inflated, provides further support to the HIFUtherapy transducer 162 and maintains the aperture of the transducer fordelivery of HIFU therapy to the patient. When inflated, the diameter ofthe ring 172, measured as a cross-section of the ring, is larger thanthe diameter of the probe 160, measured at the distal end 166 of theprobe.

In FIG. 7B, the front surface 170 of the flexible material is shown withone or more active elements 176 that are operable to generate HIFUenergy that is directed by the transducer 162 to the treatment site inthe patient. As noted earlier, HIFU generating elements are known in theart. Conduits for providing energy to the active element 176 areprovided within the probe 160. Alternatively, the front surface 170 maybe configured with a material that reflects HIFU energy toward thetreatment site. As with other implementations described herein, the HIFUenergy may be received from a source that is remote from the flexiblematerial.

Additionally, as with other implementations described herein, the distalend 166 of the probe 160 may further include an imaging component 176adapted for producing an image of a portion of the patient's body thatincludes the treatment site. Imaging of the patient in this manner mayhelp guide the delivery of HIFU energy to the treatment site. Theimaging component 176 may be configured to use reflected ultrasoundenergy or reflected light to produce the image, as described earlierherein. The image produced by the imaging component 176 may furtherinclude a portion of the HIFU therapy transducer 162 to assist inpositioning the transducer within the patient's body and in monitoringHIFU therapy being delivered at the treatment site.

FIG. 8 illustrates an implementation of a probe 180 that is likewisefitted with a flexible material having an inflatable bladder that, wheninflated, provides a HIFU therapy transducer 182. The transducer 182 mayinclude one or more active elements 184, as shown, or provide areflective mirror surface that reflects HIFU energy toward the treatmentsite. In contrast to the implementation with inflatable channels 168shown in FIGS. 7A and 7B, FIG. 8 depicts an implementation with a singleinflatable bladder 186 that, when inflated, is capable of providing HIFUtherapy to a patient. To facilitate insertion of the probe 180 in thepatient's body, the bladder 186 is not inflated until after the probe isinserted in the intended cavity of the patient's body. The bladder 186,when inflated, forms and provides lateral support to the HIFU therapytransducer 182.

Turning now to FIGS. 9A and 9B, an apparatus for delivering HIFU energyto a treatment site internal to a patient's body is shown in accordancewith another implementation of the invention. The apparatus includes anelongate probe 200 having a proximal end 202, a distal end 204, and alongitudinal axis 206 extending therebetween. The proximal end 202 ofthe probe 200 preferably has a section adapted for positioning thedistal end 204 of the probe at a desired location within the patient'sbody.

Further depicted in FIGS. 9A and 9B is a support structure 208 having animaging component 210 and a HIFU therapy transducer 212 disposedthereon. A hinge 216 connects the support structure 208 to the distalend 204 of the probe 200.

The imaging component 210 is adapted for producing an image of a portionof the patient's body that includes the treatment site, while the HIFUtherapy transducer is adapted for delivering HIFU energy to thetreatment site. The HIFU therapy transducer has an aperture of a sizesufficient to direct therapeutic HIFU energy to the treatment site andis disposed on the support structure 208 in defined relation to theimaging component 210. In the particular implementation shown, the HIFUtherapy transducer 212 is bowl-shaped, and the imaging component 210 isdisposed within the interior of the therapy transducer 212.

To facilitate insertion of the probe 200 in the patient's body, e.g.,through the vertical axis of the vaginal introitus, the supportstructure 208 is capable of rotating about the hinge 214 to an insertionposition generally parallel to the longitudinal axis 206 of the probe200, as shown in FIG. 9B. In at least one implementation, the dimensionof the therapy transducer 212 in its insertion position and measuredperpendicular to the longitudinal axis 206 of the probe is smaller thanthe dimension of the transducer 212 measured parallel to thelongitudinal axis 206. The hinge 214 provides an articulation thatenables the imaging and therapy transducers 210, 212 as a unit to bepositioned relative to the treatment site in the patient's body. In thisimplementation, the alignment of the imaging and HIFU therapy ismaintained, thus maintaining the focal range of the HIFU therapy fieldin the same region on the image plane. Advantageously, this region candetermined and calibrated at the factory. Thereafter, as a result,software control of HIFU transducer will be simpler.

After insertion of the distal end 204 of the probe 200 in a patient'sbody, the support structure 208 is capable of rotating about the hinge214 to a position non-parallel to the longitudinal axis 206 of the probe200, as may be desired to effectively aim the HIFU energy from thetherapy transducer 212 to the treatment site in the body. By rotation,the HIFU therapy transducer 212 can also be placed in a better positionfor coupling to a bodily structure, such as the uterine cervix of afemale patient.

Lastly, FIGS. 10A and 10B depict an elongate probe 220 having featuressimilar to those shown in the probe 200 of FIGS. 9A and 9B. The probe220 has a proximal end 222, a distal end 224, and a longitudinal axis226 extending therebetween. A support structure 228 bearing an imagingcomponent 230 and a HIFU therapy transducer 232 is rotatable about ahinge 234 connected to the distal end 224 of the probe 220.

In contrast to the probe 200 shown in FIGS. 9A and 9B, the imagingcomponent 230 shown in FIGS. 10A and 10B is disposed on the supportstructure 228 to the exterior of the HIFU therapy transducer 232. Havingthe imaging transducer to the exterior of the therapy transducer in somecircumstances may provide a more advantageous angle for imaging thetreatment site and the effects of the HIFU therapy being deliveredthereto.

In a suitable implementation, the imaging component 230 as well as theimaging component 210 may be configured to use reflected ultrasoundenergy to produce an image of a portion of the patient's body. In othersuitable implementations, the imaging component 230 and/or the imagingcomponent 210 may be configured to use reflected light to produce avisual image. Where reflected ultrasound energy is used to produce theimage, an implementation of the invention may use the same transducer,such as the transducers 212 and/or 232, to perform both the imaging anddelivery of HIFU therapy. Appropriate synchronization of the imaging andHIFU pulses will be desired. Nevertheless, in such cases, an imagingcomponent 210, 230 separate from the therapy transducer 212, 232 is notnecessary. If a portion of the HIFU therapy transducer is shown in theimage, the image may further assist in positioning the HIFU therapytransducer within the patient's body and in monitoring the delivery ofHIFU therapy at the treatment site.

An overall control system for the above-described probes can beimplemented using computer hardware and/or software. A control systemmay provide tools for clinicians to program a treatment strategy for aspecific region of interest in the body. The tools may include settingvarious focal lengths to treat a two-dimensional or three-dimensionalregion in the tissue, setting an appropriate power level for excitationof the HIFU transducer to obtain a desired intensity at the focus(either for a single element HIFU or a multi-element HIFU transducer)based on expected attenuation of the tissue between the HIFU transducerand the focus, setting a duration of the HIFU application, setting athreshold for power above which the system should shut down for safetypurposes, and setting a duty cycle of the HIFU exposure with respect toultrasound image acquisition. An interface may also provide tools forthe clinician to override the computer plan and design a treatment planbased on their discretion. The interface may continually update theclinician of the stage of the treatment and the next steps to be taken,as well as advise whether the plan should proceed or be altered.Finally, the interface may continually interrogate the acoustic path(pre- and post-focal) for bone and gas interfaces that could potentiallyresult in excessive energy deposition, leading to potential undesiredtissue damage.

For purposes of example only, various implementations have beendescribed above for treating pathologies of the female reproductivesystem where necrosis of a region of tissue has a therapeutic effect. Byway of example, and not by limitation, these implementations can be usedto treat uterine fibroids, adenomyoma of the uterus, adenomyosis of theuterus, endometrial polyps, endometrial ablation to achieve reduction orelimination of menstrual flow, endometrial hyperplasia, cornualpregnancy, benign ovarian cysts, pelvic endometriosis, ectopicpregnancy, and malignant lesions of the pelvic organs, whether primaryor metastatic.

As may be appreciated from the various implementations described herein,there are a variety of features and advantages obtained whenconstructing a probe in accordance with the present invention.Furthermore, although the invention has been described in connectionwith certain depicted implementations, those of ordinary skill willrecognize that one or more features of a particular implementationdescribed herein may be used in another implementation for similaradvantage. Accordingly, it is not intended that the scope of theinvention in any way be limited by the precise forms described above,but instead be determined by reference to the claims that follow andequivalents thereto.

1. An apparatus for delivering high intensity focused ultrasound (HIFU)energy to a treatment site internal to a patient's body, comprising: anelongate probe having a proximal end and a distal end, the proximal endhaving a section adapted for positioning the distal end of the probe ata desired location within the patient's body; wherein the distal end ofthe probe has a HIFU therapy transducer coupled thereto, the HIFUtherapy transducer comprising a plurality of leaves, each leaf having aproximal end, a distal end, and a deployment mechanism, wherein theproximal end of each leaf is coupled to the distal end of the probe,each leaf further having a front surface adapted to direct HIFU energyto the treatment site when the probe is inserted in the patient's bodyand the deployment mechanism is activated; wherein, when activated, thedeployment mechanism is configured to deploy the leaves by directing thedistal end of the leaves in a radially outward direction, the leavesthus deployed collectively providing a bowl-shaped HIFU therapytransducer having an outer edge with a diameter that is larger than thediameter of the probe and an aperture of a size sufficient to directtherapeutic HIFU energy to the treatment site; and wherein, tofacilitate insertion of the probe in the patient's body, the pluralityof leaves are configured to collapse when the deployment mechanism isnot activated, the collapsed leaves occupying a space having a diametersmaller than the diameter of the outer edge of the HIFU therapytransducer when the leaves are deployed.
 2. The apparatus of claim 1,wherein the elongate probe includes a sleeve disposed around a shaft,the sleeve having a proximal end, a distal end, and a longitudinal axisextending therebetween, and the shaft being configured to slide withinthe sleeve from a retracted position to an extended position along thelongitudinal axis.
 3. The apparatus of claim 2, wherein the proximal endof each leaf is coupled to a distal end of the shaft, wherein thedeployment mechanism of each leaf includes a pin coupled to the sleeve,the pin being configured to slide within a groove defined in the leaf,and wherein activation of the deployment mechanism comprises sliding theshaft within the sleeve toward the extended position, such activationcausing each leaf to be pushed outward from the distal end of thesleeve, the pin sliding within the groove in each respective leaf todirect the distal end of the leaf radially outward to a desired positionto provide the bowl-shaped HIFU transducer.
 4. The apparatus of claim 3,wherein the leaves are held within the sleeve next to the shaft when thedeployment mechanism is not activated and the shaft is in the retractedposition.
 5. The apparatus of claim 4, wherein at least a portion of aleaf in the plurality of leaves is configured to overlap at least aportion of another leaf when the leaves are held within the sleeve. 6.The apparatus of claim 3, wherein the distal end of the shaft extendsbeyond the distal end of the sleeve when the shaft is in the extendedposition, thus exposing the distal end of the shaft outside the sleeve.7. The apparatus of claim 3, wherein the pin includes a detentconfigured to secure the pin within the groove in the respective leaf.8. The apparatus of claim 3, wherein the groove in each leaf is definedat an angle relative to the longitudinal axis of the sleeve.
 9. Theapparatus of claim 2, wherein the shaft includes an actuator configuredto drive the shaft between the retracted and extended positions.
 10. Theapparatus of claim 2, wherein the proximal end of each leaf is coupledto a distal end of the sleeve, wherein the deployment mechanism of eachleaf includes a spine coupled to the shaft, the spine being configuredto slide within the sleeve into a channel defined in the leaf, andwherein activation of the deployment mechanism comprises sliding theshaft within the sleeve toward the extended position, such activationcausing the spine for each leaf to be pushed into the channel of therespective leaf to direct the distal end of the leaf radially outward toa desired position to provide the bowl-shaped HIFU transducer.
 11. Theapparatus of claim 10, wherein the spine for each leaf is held withinthe sleeve when the deployment mechanism is not activated and the shaftis in the retracted position.
 12. The apparatus of claim 10, wherein theleaves, when collapsed, are capable of being grouped together to occupya space having a diameter that is equal to or smaller than the diameterof the sleeve.
 13. The apparatus of claim 2, wherein the proximal end ofeach leaf is coupled to a distal end of the shaft, wherein thedeployment mechanism of each leaf includes a spring having a first endcoupled to the shaft and a second end disposed within the leaf, andwherein activation of the deployment mechanism comprises sliding theshaft within the sleeve toward the extended position, such activationcausing each leaf to be pushed outward from the distal end of thesleeve, the second end of the spring in each leaf being configured tobias the distal end of the respective leaf in a radially outwarddirection to a desired position to provide the bowl-shaped HIFUtransducer when the shaft is in the extended position.
 14. The apparatusof claim 1, wherein the distal end of the probe further has an imagingcomponent coupled thereto, the imaging component being adapted toproduce an image of a portion of the patient's body that includes thetreatment site to help guide the delivery of HIFU energy to thetreatment site.
 15. The apparatus of claim 14, wherein the imagingcomponent is configured to use reflected ultrasound energy to producethe image of the portion of the patient's body.
 16. The apparatus ofclaim 14, wherein the imaging component is configured to use reflectedlight to produce the image of the portion of the patient's body.
 17. Theapparatus of claim 14, wherein the image further includes a portion ofthe HIFU therapy transducer to assist in positioning the HIFU therapytransducer within the patient's body and in monitoring HIFU therapy atthe treatment site.
 18. The apparatus of claim 1, wherein the HIFUtherapy transducer is coupled to the distal end of the probe via a hingehaving an axis about which the transducer can rotate to aim the HIFUenergy toward the treatment site.
 19. The apparatus of claim 1, whereinat least a portion of the leaves are formed of an energy-activated shapememory alloy and the deployment mechanism includes a coupling of theshape memory alloy to an energy source, wherein activation of thedeployment mechanism comprises delivering energy from the energy sourceto the shape memory alloy of each leaf to cause the shape memory alloyto take a predefined shape in which the distal end of the leaves aredirected radially outward to provide the bowl-shaped HIFU transducer.20. The apparatus of claim 19, wherein the portion of the leaves formedof a shape memory alloy is configured as a spine in each leaf.
 21. Theapparatus of claim 1, further comprising an active element disposed onthe front surface of at least one of the leaves, wherein the activeelement is operable to generate the HIFU energy that is directed to thetreatment site.
 22. The apparatus of claim 1, wherein the front surfaceof at least one of the leaves is configured to reflect HIFU energytoward the treatment site, said HIFU energy being received from a sourcethat is remote from the leaf.
 23. An apparatus for delivering highintensity focused ultrasound (HIFU) energy to a treatment site internalto a patient's body, comprising: an elongate probe having a proximalend, a distal end, and a longitudinal axis extending therebetween, theproximal end of the probe having a section adapted for positioning thedistal end of the probe at a desired location within the patient's body;wherein the distal end of the probe is fitted with a flexible materialthat couples a HIFU therapy transducer to the probe, the HIFU therapytransducer having a major axis across its face and an aperture of a sizesufficient to direct therapeutic HIFU energy to the treatment site, theflexible material having a resting state in which the transducer isdeployed in a therapy position wherein the major axis of the transduceris non-parallel to the longitudinal axis of the probe; wherein, tofacilitate insertion of the probe in the patient's body, the flexiblematerial is configured to stretch and allow the transducer to be drawnto the side of the probe to an insertion position wherein the major axisof the transducer is generally parallel to the longitudinal axis of theprobe, the flexible material exhibiting a bias to return toward itsresting state after the probe has been inserted in the patient's bodyand the transducer has been released.
 24. The apparatus of claim 23,further comprising an actuator coupled to the transducer that can bemanipulated to draw the transducer to the side of the probe and todeploy the transducer to the therapy position.
 25. The apparatus ofclaim 23, wherein the distal end of the probe further includes animaging component adapted for producing an image of a portion of thepatient's body that includes the treatment site to help guide thedelivery of HIFU energy to the treatment site.
 26. The apparatus ofclaim 25, wherein the imaging component is configured to use reflectedultrasound energy to produce the image of the portion of the patient'sbody.
 27. The apparatus of claim 25, wherein the imaging component isconfigured to use reflected light to produce the image of the portion ofthe patient's body.
 28. The apparatus of claim 25, wherein the imagefurther includes a portion of the HIFU therapy transducer to assist inpositioning the HIFU therapy transducer within the patient's body and inmonitoring HIFU therapy at the treatment site.
 29. The apparatus ofclaim 23, wherein the flexible material is comprised of a resilientnon-metal material.
 30. The apparatus of claim 23, wherein the flexiblematerial is comprised of a shape memory alloy having a stretched stateor resting state dependent on energy activation of the alloy.
 31. Theapparatus of claim 23, further comprising an active element disposed onthe HIFU therapy transducer, wherein the active element is operablegenerate the HIFU energy that is directed to the treatment site.
 32. Theapparatus of claim 23, wherein the HIFU therapy transducer is configuredto reflect HIFU energy toward the treatment site, said HIFU energy beingreceived from a source that is remote from the transducer.
 33. Anapparatus for delivering high intensity focused ultrasound (HIFU) energyto a treatment site internal to a patient's body, comprising: anelongate probe having a proximal end and a distal end, the proximal endof the probe having a section adapted for positioning the distal end ofthe probe at a desired location within the patient's body; wherein thedistal end of the probe is fitted with a flexible material having one ormore inflatable bladders that, when inflated, provide a HIFU therapytransducer having an aperture of a size sufficient to direct therapeuticHIFU energy to the treatment site, the inflatable bladders extendingradially outward from the distal end of the probe, and wherein, tofacilitate insertion of the probe in the patient's body, the bladdersare not inflated until after the probe is inserted in the patient'sbody; the flexible material further having a front surface adapted todirect HIFU energy to the treatment site when the probe is inserted inthe patient's body and the bladders are inflated, and wherein, wheninflated, the bladders provide lateral support to the HIFU therapytransducer and the transducer has an aperture that is larger than thediameter of the probe.
 34. The apparatus of claim 33, wherein thebladders comprise one or more inflatable channels that extend radiallyoutward from the distal end of the probe, and wherein the front face ofthe flexible material extends between the inflatable channels.
 35. Theapparatus of claim 34, wherein the inflatable channels terminate in aninflatable ring that forms an outer edge of the HIFU therapy transducer.36. The apparatus of claim 35, wherein when inflated, the diameter ofthe ring is larger than the diameter of the probe.
 37. The apparatus ofclaim 33, further comprising an active element disposed on the frontsurface of the flexible material, wherein the active element is operablegenerate the HIFU energy that is directed to the treatment site.
 38. Theapparatus of claim 33, wherein the front surface of the flexiblematerial is configured to reflect HIFU energy toward the treatment site,said HIFU energy being received from a source that is remote from theflexible material.
 39. The apparatus of claim 33, wherein the distal endof the probe further includes an imaging component adapted for producingan image of a portion of the patient's body that includes the treatmentsite to help guide the delivery of HIFU energy to the treatment site.40. The apparatus of claim 39, wherein the imaging component isconfigured to use reflected ultrasound energy to produce the image ofthe portion of the patient's body.
 41. The apparatus of claim 39,wherein the imaging component is configured to use reflected light toproduce the image of the portion of the patient's body.
 42. Theapparatus of claim 39, wherein the image further includes a portion ofthe HIFU therapy transducer to assist in positioning the HIFU therapytransducer within the patient's body and in monitoring HIFU therapy atthe treatment site.
 43. The apparatus of claim 33, wherein the bladders,when not inflated, occupy a space having a diameter smaller than thediameter of the HIFU therapy transducer when the bladders are inflated.44. The apparatus of claim 33, wherein the bladders are inflated using afluid that is circulated to and from the bladders to control atemperature of the HIFU therapy transducer and tissue adjacent to theHIFU therapy transducer when the probe is inserted into the patient. 45.An apparatus for delivering image-guided high intensity focusedultrasound (HIFU) energy to a treatment site internal to a patient'sbody, comprising: an elongate probe having a proximal end, a distal end,and a longitudinal axis extending therebetween, the proximal end of theprobe having a section adapted for positioning the distal end of theprobe at a desired location within the patient's body; a supportstructure having an imaging component and a HIFU therapy transducerdisposed thereon; and a hinge connecting the support structure to thedistal end of the probe, wherein the imaging component is adapted forproducing an image of a portion of the patient's body that includes thetreatment site, wherein the HIFU therapy transducer has an aperture of asize sufficient to direct therapeutic HIFU energy to the treatment siteand is disposed on the support structure in defined relation to theimaging component, and wherein, to facilitate insertion of the probe inthe patient's body, the support structure is capable of rotating aboutthe hinge to an insertion position generally parallel to thelongitudinal axis of the probe, and after insertion of the probe in thepatient's body, the support structure is capable of rotating about thehinge to a position non-parallel to the longitudinal axis of the probe,the hinge providing an articulation that enables the imaging and therapytransducers as a unit to be positioned relative to the treatment site inthe patient's body.
 46. The apparatus of claim 45, wherein the HIFUtherapy transducer is bowl-shaped and the imaging component is disposedwithin the interior of the therapy transducer.
 47. The apparatus ofclaim 45, wherein the imaging component is disposed on the supportstructure to the exterior of the HIFU therapy transducer.
 48. Theapparatus of claim 45, wherein the imaging component is configured touse reflected ultrasound energy to produce the image of the portion ofthe patient's body.
 49. The apparatus of claim 48, wherein the imagingand delivery of HIFU therapy are performed using same transducer. 50.The apparatus of claim 45, wherein the imaging component is configuredto use reflected light to produce the image of the portion of thepatient's body.
 51. The apparatus of claim 45, wherein the imageproduced by the imaging component includes a portion of the HIFU therapytransducer to assist in positioning the HIFU therapy transducer withinthe patient's body and in monitoring HIFU therapy at the treatment site.52. The apparatus of claim 45, wherein the dimension of the therapytransducer in its insertion position and measured perpendicular to thelongitudinal axis of the probe is smaller than the dimension of thetransducer measured parallel to the longitudinal axis.